NDAORALTABLET
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
NILANDRON (nilutamide) by ANI Pharmaceuticals is androgen receptor antagonists [moa]. First approved in 1996.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NILANDRON (nilutamide) is an oral androgen receptor antagonist approved in 1996 for the treatment of metastatic prostate cancer. It blocks androgen signaling by inhibiting the androgen receptor, thereby suppressing tumor growth in hormone-sensitive disease. This small-molecule therapy is typically used as adjunctive treatment in combination with surgical castration or LHRH agonists.
$0.047MPart D
LOE ApproachingDeclining
With LOE approaching and minimal Part D claims (20 in 2023), NILANDRON is in decline phase, suggesting a lean brand team focused on contract manufacturing and legacy support rather than growth initiatives.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer
Started May 2009
57 enrolled
Prostate Cancer
Career Relevance
Working on NILANDRON offers limited commercial growth opportunities but provides stable, specialized experience in legacy product management, regulatory compliance, and generic competition strategy. Roles focus on operational efficiency, cost containment, and maintaining market share against generic and biosimilar erosion rather than market expansion.
Regulatory Affairs Specialist
Worked on NILANDRON at ANI Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.